At the Irish Pharma Industry Awards this Thursday, October 24, a CCID project with Pfizer and Lilly has been shortlisted under the Partnership Alliance of the Year.
The partnership awas an Enterprise Ireland Innovation Partnership Project between Pfizer (with team members based in Ringaskiddy, Cork, Ireland, Groton, Connecticut, US and Singapore), Eli Lilly (with team members based in Kinsale, Cork, Ireland, and Indianapolis, US) and the SSPC Research Centre at the Bernal Institute, University of Limerick, with the key objective of developing flexible platforms for Continuous Crystallization, Isolation and Drying (CCID) from existing off the shelf technology for real-world active pharmaceutical ingredients (APIs).
CCID was a hugely successful partnership project. All activities took place with the full involvement of company and academic team members. Initial activities focused on defining the selection criteria for the API system, the crystallization unit, the isolation technology and the drying technology. This placed the UL researchers routinely at the company’s sites. Once the equipment was in place (Eli-Lilly donated a lab scale 2-pot MSMPR to UL, Pfizer donated API material and a lab scale isolation unit) experimental testing of the unit operations took place at the University. The US Research and Development Centres of both companies also supported the project and participated in meetings throughout the duration of the project. Company team members provided input to the experimental testing, the UL researchers presented regular progress up-dates at monthly technical meetings via video conferencing allowing the US and Singapore based researchers of both companies to participate.
The UL researchers also regularly visited the Irish sites for technical meetings. A Lilly engineer and technician supported equipment installation locally at the UL laboratories. The two full-time UL researchers and a Pfizer Ireland colleague travelled to the US for face-to-face meetings with partners in the US sites in Indianapolis and Groton. They visited vendors with the US based Pfizer scientists. The US based Pfizer scientists also visited the Lilly site in Indianapolis for face to face meetings and site tours with scientists working at the cutting edge of continuous API manufacturing.
The UL crystallisation process was successfully scaled up at the Kilo Technology Laboratory (KTL, Cork) in Pfizer by Pfizer technical staff following a technology handover (figure 2). The UL researchers supported the demonstrations and Eli Lilly researchers were also in attendance, this in itself is a first for Irish academia and testament to the potential value realized in this work. The KTL also successful demonstrated the continuous isolation of API by integrating the high frequency filter to the continuous crystalliser, generating 10kg of API per 24-hour period.
CCID also leverage existing administration support structures within the SSPC, existing as an SSPC –associated project, and took advantage of existing SSPC procedures in relation to industrial interactions, Intellectual Property Management and Heads of Agreement.
The global project team consisted of:
University of Limerick: Denise Croker, Barbara Wood, Christian Bouani/Jude Ngadaoyne, Rory Tyrell, Gavin Walker, Kieran Hodnett and David Egan.
Pfizer: Liam Tully, Patrick Sweeney, Edel Hughes, Kevin Girard, David Pfisterer, David Walker, Pushkar Pendse Vincent Irwin.
Eli-Lilly: Stephen Jeffery, Ciara Hood, Melba Simon, Ed Conder, Chris Polster